Résultats de la recherche - 15 results
Pyrogen testing of phage therapeutic products
contamination (e.g. cell wall debris) is a major safety concern as these pro-inflammatory agents can cause unwanted clinical reactions with potential detrimental outcome. The most common and potent pyrogens are ...
Validation of an animal-free analytical method for the detection of bacterial endotoxins in human vaccines
3R (2023) Keywords: Endotoxin " vaccine " quality control " recombinant factor c " LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following ...
Determination of vaccine bacterial endotoxins content by the rFC method
factor c; LAL Abstract: Sciensano, as official medicines control laboratory (OMCL) following “Official Control Authority Batch Release” (OCABR) guidelines, is entitled to check the concentration of ...
Homologous versus heterologous prime-boost COVID-19 vaccination: impact on clinical severity of Omicron among hospitalized COVID-19 patients in Belgium
in-hospital mortality, and severe COVID-19 – defined as experiencing an acute respiratory distress syndrome (ARDS) event, or an ICU transfer, or in-hospital mortality) for patients that received a homologous ...
The GEONs API-fingerprint program: Tackling falsifications of APIs
API fingerprint GEON Abstract: Falsification of active pharmaceutical ingredients (API s) has been recognized as an important health issue since a series of health scares involving large numbers of ...
Development of a multiplex immunoassay for simultaneous detection of antigens in DTaP vaccines
development and optimization of the Luminex assay with non-adsorbed antigens and, later, with complete vaccine formulation from HuA and HuB. All selected antibody pairs were tested as capture or detection ...
Characterization and hazard identification of substandard and falsified antimicrobials encountered in Belgium
together with anti-malarials, one of the most popular medicines that have been encountered as illegal substandard and falsified (SF) medical products. It has been demonstrated that SF products of these ...
Identification of Flavouring Substances of Genotoxic Concern Present in E-Cigarette Refills
prioritize the substances of highest concern for human health. In this context, genotoxicity is a key (toxicological) endpoint as it is related to a broad range of adverse human health effects including ...
First Belgian national EQA for special stains in histopathology
the slides (sectioning and coverslipping), of the hematoxylin and eosin (HE)stain and of four special stains (PAS, reticulin, trichrome and Perls), as submitted by the participants, wasevaluated. All ...
Evolution of the implementation of a quality management system in the Belgian laboratories for anatomic pathology
computerized systems as stated in the articles 22, 24, 26, 27, 28 and 29 of the RD, respectively, should be fulfilled within a time period of three months counting from the entry into force of the license. ...